Supervisor, Quality Assurance and Compliance
Libertyville, Illinois, United States
Job type: fulltime
Job industry: Other
Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.
AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.
The Compliance Supervisor will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have expert knowledge and application of the CFRs and cGMPs and have been involved in regulatory inspections. The Compliance Supervisor is responsible for making quality decisions and addressing or resolving issues based on experience, written procedures and analytical analysis. They are also responsible for the oversight of the material specification and material release processes, supervision of all activities related to incoming material release, supplier corrective actions, regulatory audits, complaints, annual product quality review, and quality management review.
- Supervise Quality Assurance/ Compliance Associates by providing work direction, time approval, performance management and professional development.
- Manage the review and release of incoming materials to align with the manufacturing schedule and company timelines.
- Manage the complaint process for both clinical and commercial complaints.
- Responsible for supporting the development and implementation of robust quality systems including:
- SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to operations and other cGMP activities
- Deviation/CAPA Management approval: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Requires direct input on the creation and effectiveness of Corrective and Preventive Action plans. Assist with implementation and supporting on-going continuous improvements.
- Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations.
- Manage site inspection preparation, inspection logistics and execution, and response process.
- Partner with other functional business units, including Manufacturing and MS&T, to resolve documentation and raw material specification related issues.
- Review supplier corrective action requests to identify trends and work with the appropriate suppliers to drive robust corrective actions
- Manage the monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
- Manage the printed material issuance and reconciliation process to ensure patient doses are packed and released within pre-defined timelines.
- Minimum B.S. degree; life sciences background or emphasis preferred
- Minimum of 6+ years of experience in biopharmaceutical based GMP manufacturing operations
- Experience with viral gene therapies and/or orphan disease indications is a plus.
- Previous experience with supervision of teams and processes is preferred.
- Comprehensive knowledge of FDA and EU regulations and direct experience in US and international regulatory agency inspections.
- Direct experience reviewing and/or authoring standard operating procedures and review and approval of investigations and deviations.
- Excellent oral and written communication skills with strong technical writing experience.
- Experience supporting audits, identifying findings, driving resolution and providing a closure report.
- Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
- Must have strong knowledge and application of the CFRs and cGMPs.
The level of this position will be based on the final candidate's qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.